Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)
- Conditions
- Breakthrough Pain
- Interventions
- Other: No intervention
- Registration Number
- NCT03435120
- Lead Sponsor
- Angelini Farmacéutica
- Brief Summary
In cancer patients, pain is one of the most common symptoms. The range of reported prevalence of pain varies from 33% to 64% including different stages of cancer, during or after anticancer treatment. Moreover, despite the optimal management of basal chronic pain, 66% of these patients have reported breakthrough pain which has a severe impact on quality of life. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in medical oncology services according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain in medical oncology services as well as other factors that can affect quality of life. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in medical oncology services in Spanish hospitals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- Patients > 18 years
- Patients with histologically confirmed neoplasia
- Patients attended in medical oncology consultations
- Life expectancy > 3 months
- Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm
- Written informed consent
- Untreated patients with opioids for baseline pain
- Patients who are not opioid tolerant
- Serious psychiatric disorder or any disease or condition that prevents the collection of data
- Patients with evidence of opioid addiction or history of drug or alcohol abuse
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Breakthrough Cancer Pain No intervention No intervention (Non Interventional Study)
- Primary Outcome Measures
Name Time Method Changes in quality of life of the patients Up to 4 weeks Changes according to EQ-5D-5L questionnaire
- Secondary Outcome Measures
Name Time Method Characteristics of patients At baseline ECOG
Management of cancer breakthrough pain. Up to 4 weeks Cancer breakthrough pain evolution (duration and management)
Anxiety and depression status and the possible relationship between these factors and quality of life. Up to 4 weeks Goldberg Anxiety and Depression Scale.
Sleep quality and the possible relationship between this factor and quality of life. Up to 4 weeks MOS sleep questionnaire
Evaluate caregivers effort Up to 4 weeks Results according to caregivers effort Index
Perceived assistance quality by patients Up to 4 weeks Results according to Sociofamily evaluation scale of "Gijon"
Improvement impression perceived by patients Up to 4 weeks Results according to Satisfaction questionnaire CGI-I
Trial Locations
- Locations (14)
Complexo Hospitalario Universitario de Santiago
🇪🇸Santiago De Compostela, A Coruña, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Verge de la Cinta
🇪🇸Tortosa, Tarragona, Spain
Hospital Principe de Asturias
🇪🇸Alcalá De Henares, Madrid, Spain
Hospital Universitari Son Espases
🇪🇸Palma De Mallorca, Palma, Spain
Hospital Universitari de San Joan de Reus
🇪🇸Reus, Tarragona, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain